None listed
Conditions
Brief summary
Brief description of the study purpose This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans. Who is it for? Healthy adult men aged 18 to 65 years who meet the study eligibility criteria. Study details Participants will be randomly assigned to receive either SCB0020160 or placebo. The study includes single-dose and multiple-dose treatment periods, as well as an assessment of the effect of food on the absorption of SCB0020160. Participants will undergo safety assessments including physical examinations, vital signs, ECGs, blood and urine tests, and monitoring of adverse events. The study will also assess how SCB0020160 is processed by the body. There is no direct health benefit expected from participation. The results may help determine safe dose levels and support future clinical development of SCB0020160.
Interventions
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of SCB0020160 or placebo after single
and multiple oral administrations in healthy adult male subjects. Considering that the objectives of this study are
exploratory in nature, it differs from studies for typical statistical hypothesis testing. It is desirable to proceed with the
number of subjects required empirically within the limits of satisfying the study objectives, rather than based on a
specific formula. Th
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of SCB0020160 or placebo after single and multiple oral administrations in healthy adult male subjects. Considering that the objectives of this study are exploratory in nature, it differs from studies for typical statistical hypothesis testing. It is desirable to proceed with the number of subjects required empirically within the limits of satisfying the study objectives, rather than based on a specific formula. Therefore, the total number of subjects in this study was set to 74 in total (target subjects: 8 subjects per dose group, substitute subjects: 10 subjects in total). Among them, 10 were substitute subjects, and when all 64 subjects (8 per dose group) complete the study, the study can be closed without recruiting/enrolling substitute subjects. Part A single-dose study (including food effect study): 40 subjects The study consists of five dose groups. In Dose Group 1: 8 subjects will receive either SCB0020160 delayed-release capsules at a dose of 50 mg (1 capsule; 6 subjects) or matching placebo (2 subjects). In Dose Group 2: 8 subjects will receive 100 mg of SCB0020160 (two 50 mg capsules; 6 subjects) or placebo (2 subjects). In Dose Group 3: 8 subjects will receive 200 mg of SCB0020160 (four 50 mg capsules; 6 subjects) or placebo (2 subjects). In Dose Group 4 (food-effect group): 8 subjects will receive 400 mg of SCB0020160 (eight 50 mg capsules; 6 subjects) or placebo (2 subjects). In Dose Group 5: 8 subjects will receive 600 mg of SCB0020160 (twelve 50 mg capsules; 6 subjects) or placebo (2 subjects) Part B multiple-dose study: 24 subjects The study includes three dose groups. In Dose Group 1: a total of 8 subjects will receive either SCB0020160 delayed-release capsules at a dose of 200 mg (four 50 mg capsules; 6 subjects) or matching placebo (four 50 mg capsules; 2 subjects). In Dose Group 2: 8 subjects will receive 400 mg of SCB0020160 (eight 50 mg capsules; 6 subjects) or placebo (eight 50 mg capsules; 2 subjects). In Dose Group 3: 8 subjects will receive 600 mg of SCB0020160 (twelve 50 mg capsules; 6 subjects) or placebo (twelve 50 mg capsules; 2 subjects)." For Part A, initiation of each subsequent dose cohort will be dependent on review of available safety, tolerability and pharmacokinetic data from the preceding cohort and approval by the SRC. Subjects randomized to placebo in the food-effect cohort will receive matching placebo under the same fed conditions as active-treated subjects. Subjects in the food-effect cohort will receive study treatment following a high-fat, high-calorie meal (approximately 800–1000 kcal, with approximately 50% of calories derived from fat). Subjects in all other cohorts will receive study treatment following an overnight fast of at least 10 hours. All dosing will be administered under direct supervision of study personnel during site confinement. Compliance will be assessed through direct observation and investigational product accountability records. For Part B, initiation will occur following review of available safety, tolerability and pharmacokinetic data from Part A and approval by the Safety Review Committee (SRC). Subjects in Part B will receive study treatment under fasting conditions consistent with the non-food-effect cohorts in Part A. Subjects in Part B will receive once-daily dosing for 14 consecutive days. Compliance will be assessed through direct observation of dosing and investigational product accountability records.
Sponsors
SCBIO Inc
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1) Healthy adult male volunteers in the opinion of the principal investigator or delegate, aged 18 to 65 years at screening 2) Body weight more than or equal to 45.0 kg at screening, with a body mass index (BMI) of more than or equal to 18.0 kg/m² and less than or equal to 32.0 kg/m² 3) Eligible to participate in the study based on the results of physical examination, clinical laboratory tests, history taking, and other examinations performed at screening, as determined by the principal investigator or delegate. 4) Has voluntarily decided to participate and provided written or electronic consent to comply with the precautions after receiving a full explanation of the study and fully understanding it.
Exclusion criteria
1. Has or has ever had any serious medical condition, including diseases of the liver, kidneys, brain or nerves, immune system, lungs, stomach or intestines, hormones, blood, cancer, heart, urinary system, mental health conditions, or problems related to sexual function. 2. Has or has ever had stomach or bowel diseases such as Crohn’s disease or ulcerative colitis or has had surgery on the stomach or intestines (except appendix removal or hernia surgery). 3. Has a history of allergy or sensitivity to the study medicine, similar medicines, or other medicines such as aspirin or antibiotics. 4. Has inherited problems with digestion of sugars, such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. 5. Has abnormal vital signs at screening after resting for at least 5 minutes, including: * Very low or high blood pressure * Very slow or very fast heart rate 6. Has an abnormal heart rhythm on the ECG test or any heart rhythm problem considered important by the doctor. 7. Has abnormal results in screening blood or urine tests, including: * Poor kidney function * Abnormal blood sugar levels * Abnormal liver enzyme levels * High cholesterol levels * High triglyceride levels 8. Drinks large amounts of alcohol regularly or is unable to stop drinking alcohol from 3 days before the first dose until the end of the study. 9. Has a positive alcohol breath test at screening or on the day before dosing. 10. Currently smokes cigarettes (participants who stopped smoking at least 3 months before the study may be eligible). 11. Has a positive urine test for nicotine or tobacco products at screening or on the day before dosing. 12. Has taken prescription medicines or herbal medicines within 2 weeks before the study, or has taken over-the-counter medicines, vitamins, health supplements, or liver supplements within 1 week before the study, or plans to take them during the study (unless allowed by the study doctor). 13. Has taken medicines that strongly affect drug metabolism within 1 month before the study. 14. Has a history of drug or alcohol misuse or has a positive urine test for recreational drugs. 15. Has participated in another clinical trial or received any investigational medicine within 3 months before this study. 16. Has donated blood within the last 2 months, donated blood components within the last 1 month, or received a blood transfusion within the last 1 month. 17. Drinks excessive caffeine regularly or is unable to stop consuming caffeine-containing products such as coffee, tea, soft drinks, energy drinks, or caffeine supplements from 3 days before dosing until the end of the study. 18. Has consumed grapefruit or grapefruit-containing foods or drinks within 3 days before dosing or is unable to avoid them during the study. 19. Has unusual eating habits or is unable to follow the standard meals provided by the study site during the inpatient stay. 20. Has tested positive for infections such as hepatitis B, hepatitis C, HIV, or syphilis. 21. Does not agree to use reliable birth control during the study and for 90 days after the last dose or does not agree to avoid donating sperm or eggs during this period. Acceptable birth control methods include medically approved contraceptive devices, sterilization, confirmed absence of sperm, long-term hormonal contraception with condom use, or complete sexual abstinence. 22. Is considered unsuitable for the study by the study doctor for any other reason, including inability to follow study requirements.
Outcome results
None listed